CN114617613B

CN114617613B - Coronary artery rotational atherectomy intervention system

Info

Publication number: CN114617613B
Application number: CN202210530671.3A
Authority: CN
Inventors: 沈斌
Original assignee: Guangzhou Boxin Medical Technology Co ltd
Current assignee: Jiaxing Jiangxin Medical Technology Co ltd
Priority date: 2022-05-16
Filing date: 2022-05-16
Publication date: 2022-08-16
Anticipated expiration: 2042-05-16
Also published as: CN114617613A

Abstract

In the coronary artery rotational atherectomy intervention system provided by the invention, a limit switch in a guide wire clamping system is connected with a limit switch state detection and transmission module, and after the guide wire is clamped, the limit switch is triggered to be in a closed state and is detected by the limit switch state detection and transmission module; in the normal saline infusion system, an infusion pump control element is connected with an infusion pump, the infusion pump control element can control the infusion pump to be in a starting state, and the infusion pump is connected with an infusion pump state detection and transmission module, so that the starting state of the infusion pump can be detected by the infusion pump state detection and transmission module; after the controller module in the driving and controlling system confirms that the infusion pump of the physiological saline filling system is in a starting state and the limit switch is in a closed state, an instruction for starting the driving motor is sent out, so that the rotary grinding head is driven to rotate, and the operation safety of the device is obviously improved.

Description

Coronary artery rotational atherectomy intervention system

Technical Field

The invention relates to the technical field of medical instruments, in particular to a rotational atherectomy interventional system.

Background

Plaque in the coronary arteries of a living being (e.g., a human) is an obstruction created by the deposition of calcium ions in the arterial blood vessels on the inner walls of the blood vessels, which slows or even blocks the flow of blood, thereby causing a number of ischemic heart diseases. The coronary artery rotational grinding interventional system is a device for treating coronary artery calcification lesion by utilizing interventional treatment and rotating a plaque into tiny particles through a rotational grinding head at a high speed and then absorbing the tiny particles by a human body.

When carrying out intervention formula rotational abrasion treatment, the guide wire inserts pathological change coronary artery department earlier, and the drive shaft that has the head of rotational abrasion subsequently penetrates to the pathological change position along the guide wire, and the starter motor, the high-speed rotatory calcified plaque of grinding of the head of rotational abrasion, the plaque piece size after the rotational abrasion is very little, can not block up capillary, can finally be engulfed by the macrophage and clear away. The rotary grinding head is fed back and forth, so that the calcified plaque tissue can be ground at a certain distance, and finally the intervention treatment of coronary calcified lesion is completed. In the interventional therapy process, the temperature rise caused by the high-speed rotation of the rotary grinding head is reduced through the perfusion of the normal saline, so that the normal internal temperature environment of a patient is prevented from being influenced.

Disclosure of Invention

Based on the above situation, the main object of the present invention is to provide a rotational atherectomy interventional system, so as to significantly improve the operational safety of the rotational atherectomy interventional system.

In order to achieve the purpose, the technical scheme adopted by the invention is as follows:

the invention provides a rotational atherectomy intervention system for coronary arteries, which comprises a rotational atherectomy mechanism, a normal saline perfusion system, a driving and control system and a guide wire clamping system;

the rotary grinding mechanism comprises a guide wire, a driving shaft assembly and a rotary grinding head;

the guide wire clamping system comprises a limit switch and a limit switch state detection and transmission module, the limit switch is connected with the limit switch state detection and transmission module, and after the guide wire is clamped, the limit switch is triggered to be in a closed state and is detected by the limit switch state detection and transmission module;

the normal saline infusion system comprises an infusion pump, an infusion pump control element and an infusion pump state detection and transmission module, wherein the infusion pump control element is connected with the infusion pump, the infusion pump control element can control the infusion pump to be in a starting state, and the infusion pump is connected with the infusion pump state detection and transmission module, so that the starting state of the infusion pump can be detected by the infusion pump state detection and transmission module;

the driving and control system comprises a driving motor and a controller module, and the limit switch state detection and transmission module and the infusion pump state detection and transmission module are respectively connected with the controller module so as to transmit state data to the controller module;

the controller module confirms that the infusion pump of the normal saline filling system is in a starting state and the limit switch is in a closed state, and then sends out a command for starting the driving motor so as to enable the driving motor to rotate, and further the rotating head is driven by the driving shaft assembly to rotate together.

Preferably, the drive shaft assembly comprises a drive shaft comprising a rigid shaft and a flexible shaft fixedly connected to a front side of the rigid shaft, the rotational head being formed at an end of the flexible shaft remote from the rigid shaft, the rotational head comprising an eccentric structure in a circumferential direction around the flexible shaft; the eccentric structure comprises a cylindrical section, and in different radial directions of the cross section of the cylindrical section, a connecting line of a first point of the outer wall surface of the cylindrical section, which is closest to the central axis of the flexible shaft, and a second point, which is farthest from the central axis of the flexible shaft, is crossed with the central axis of the flexible shaft; the straight-line distance between the first point and the second point is 0.8-1.2mm, and the difference between the distance from the second point to the central axis and the distance from the first point to the central axis is 0.05-0.2 mm.

Preferably, the straight-line distance between the first point and the second point is 0.9mm, and the difference between the distance from the second point to the central axis and the distance from the first point to the central axis is 0.1 mm.

Preferably, the rotational grinding head further comprises a tapered portion located at the front end of the eccentric structure, the tapered portion is coaxial with the flexible shaft, a large diameter end of the tapered portion is connected with the eccentric structure, the eccentric structure further comprises a first eccentric taper section and a second eccentric taper section located at the front end and the rear end of the cylindrical section respectively, wherein a small diameter end of the first eccentric taper section is connected with a large diameter end of the tapered portion, the large diameter end of the first eccentric taper section is connected with the front end of the cylindrical section, the large diameter end of the second eccentric taper section is connected with the rear end of the cylindrical section, and the small diameter end of the second eccentric taper section is connected with the outer circumferential surface of the flexible shaft; the conical part is made of stainless steel, and the outer surface of the conical part is a smooth surface; the eccentric structure comprises an electroformed nickel substrate and abrasive particles galvanically embedded in the substrate.

Preferably, the axial dimension of the conical part accounts for 30% -40% of the axial dimension of the rotary grinding head, the axial dimension of the cylindrical section accounts for 40% -50% of the axial dimension of the rotary grinding head, and the ratio of the diameter of the cylindrical section to the axial dimension of the eccentric structure is 0.6-0.7.

Preferably, after the infusion pump control element controls the infusion pump to start, the infusion pump state detection and transmission module sends a first indication signal to the controller module so that the controller module can confirm that the infusion pump is in a started state.

Preferably, the drive and control system still includes the opto-coupler, the opto-coupler be located the transfer pump state detect with transmission module with between the controller module, the opto-coupler receives first instruction signal sends after the processing to the controller module.

Preferably, after the limit switch is closed, the limit switch state detection and transmission module sends a second indication signal to the controller module, so that the controller module can confirm that the limit switch is in a closed state.

Preferably, the driving and control system further comprises a motor driving module and a speed detection module, the controller module is connected with both the motor driving module and the speed detection module, the driving motor is connected with both the motor driving module and the speed detection module, the motor driving module drives the driving motor under the control of the controller module, and the speed detection module feeds back real-time speed information of the driving motor to the controller module; when the real-time measured motor rotating speed is greater than or less than the preset speed, a controller module in the control system controls the motor driving module to adjust the rotating speed of the driving motor to the preset speed.

Preferably, drive and control system still includes display screen, many gears knob switch, gear information processing module and motor drive module, many gears knob switch connect gear information processing module, gear information processing module connects the controller module, the controller module is connected motor drive module, motor drive module connects driving motor is on selected gear with control driving motor's rotational speed, the display screen sets to become 30 degrees contained angles with the horizontal plane for show driving motor's rotational speed and grind the time soon.

Preferably, drive and control system still includes sampling resistance, sampling resistance voltage acquisition module, amplifier, enlarged voltage information transmission module and motor drive module, driving motor connects sampling resistance, sampling resistance connects sampling resistance voltage acquisition module, sampling resistance voltage acquisition module connects the amplifier, enlarged voltage information transmission module is connected to the amplifier, enlarged voltage information transmission module connects the controller module, the controller module is connected the motor drive module, the motor drive module is connected driving motor, when the overload takes place, controller module control motor drive module stops the drive driving motor, makes driving motor stop the operation.

Preferably, the drive and control system further comprises a motor drive module; the physiological saline perfusion system also comprises a plurality of flow rate regulating circuits and a physiological saline perfusion control motor, wherein the flow rate regulating circuits comprise a plurality of resistors and a plurality of flow rate selection switches, the resistance values of the resistors are different from each other, the flow rate regulating circuits, the flow rate selection switches and the resistors are the same in number, one flow rate selection switch and one resistor are connected in series in the same flow rate regulating circuit, and each flow rate regulating circuit is connected with the controller module; the controller module is connected with the normal saline perfusion control motor, controls the rotating speed of the normal saline perfusion control motor and further controls the perfusion speed of the normal saline.

Preferably, the saline solution filling control motor drives the infusion pump, and as the rotation speed of the saline solution filling control motor is increased or decreased, the rotation speed of the infusion pump is increased or decreased, and the filling speed of the saline solution is increased or decreased along with the change of the rotation speed of the infusion pump, so as to control the filling speed of the saline solution.

Preferably, the drive shaft assembly comprises a drive shaft and a drive shaft sleeve; the driving and control system further comprises a driving gear and a transmission gear, one part of the driving shaft is fixedly arranged on the transmission gear, at least one part of the driving shaft which is not fixedly arranged in the rest part of the transmission gear and at least one part of the guide wire are positioned in the driving shaft sleeve; the driving shaft sleeve comprises a front side sleeve and a rear side sleeve, the front side sleeve comprises a front side movable rail pipe and a front side fixed rail pipe which are nested, and the front side sleeve is positioned in front of the transmission gear; the rear side sleeve comprises a rear side movable rail pipe and a rear side fixed rail pipe which are nested, and the rear side sleeve is positioned behind the transmission gear;

a first friction reducing tube is provided between the drive shaft and the front side moving rail tube, and/or a second friction reducing tube is provided between the drive shaft and the rear side moving rail tube, and/or a friction reducing coating is provided on at least a portion of the outer surface of the drive shaft.

Preferably, a flexible sealing ring is arranged outside the front movable rail pipe, and the inner diameter of the sealing ring is smaller than the outer diameter of the front movable rail pipe in a natural state; and a flexible sealing ring is arranged outside the rear movable rail pipe, and the inner diameter of the sealing ring is smaller than the outer diameter of the rear movable rail pipe in a natural state.

Preferably, the limit switch is fixed opposite to the back wall of the housing of the coronary rotational atherectomy interventional system and extends out of the back wall;

the guide wire clamping system comprises a multi-jaw chuck, a chuck cover and a chuck cover fixing seat,

the multi-jaw chuck comprises a chuck part formed by a plurality of mutually independent jaws and a main body part used for fixedly connecting the plurality of mutually independent jaws, the main body part is arranged in the chuck cover, and the chuck part extends into the chuck cover fixing seat;

the chuck cover fixing seat is relatively fixed with the rear wall, the part of the chuck cover fixing seat behind the rear wall is provided with external threads, the rear opening of the chuck cover fixing seat is used for the chuck part to extend into, and the rear opening internally comprises a conical multi-jaw chuck clamping part;

the inner part of the chuck cover is provided with an internal thread matched with the external thread, and the chuck cover is fixed on the chuck cover fixing seat through the matching of the internal thread and the external thread;

the multi-jaw chuck has elasticity, after the guide wire is inserted into the multi-jaw chuck, the chuck part of the multi-jaw chuck can be expanded, after the chuck cover is screwed relative to the chuck cover fixing seat, an interference fit can be formed between the multi-jaw chuck clamping part and the expanded chuck part, and the interference fit clamps the chuck part, so that the guide wire is clamped by the multi-jaw chuck;

after the chuck cover is screwed down relative to the chuck cover fixing seat, the front end face of the chuck cover can press the limit switch to trigger the limit switch to be in a closed state.

Preferably, the chuck cover comprises a first cylindrical stopping structure, a second stopping structure is further arranged inside the chuck cover, and after the chuck cover is screwed down relative to the chuck cover fixing seat, the first stopping structure and the second stopping structure can stop the multi-jaw chuck from moving backwards.

Preferably, the guide wire clamping system further comprises a flexible sealing structure, the flexible sealing structure is provided with a first through hole for a guide wire to pass through, in a natural state, the diameter of the first through hole is not larger than that of the guide wire, the flexible sealing structure is located inside the chuck cover and behind the second stopping structure, and the front end face of the flexible sealing structure abuts against the rear end face of the second stopping structure.

Preferably, the driving and control system further comprises a timing module and an alarm device, wherein the timing module is connected with the controller module and is used for timing the rotation of the driving motor, and when the single rotation time of the driving motor reaches a first preset time or the multiple accumulated rotation time of the driving motor reaches a second preset time, the controller module controls the alarm device to give an alarm.

According to the coronary artery rotational grinding interventional system, before the driving motor is started to enable the rotational grinding device to start the rotational grinding operation on the plaque in the blood vessel of the living body, whether the infusion pump of the normal saline infusion system is in the started state and whether the limit switch is in the closed state are firstly confirmed, so that the extremely large injury to the human body caused by the fact that the rotational grinding operation is started under the state that no normal saline is supplied or the guide wire is not clamped is avoided, the health and safety of the human body are effectively guaranteed, the fact that whether the normal saline can be supplied or not and the guide wire is clamped does not need to be checked by special manpower, the operation convenience is obviously optimized, and the operation experience is effectively improved.

Other advantages of the present invention will be described in the detailed description, and those skilled in the art will understand the technical features and technical solutions presented in the description.

Drawings

Preferred embodiments of the present invention will be described below with reference to the accompanying drawings. In the figure:

FIG. 1 is a schematic perspective view of a preferred embodiment of a rotational atherectomy interventional system of the present invention (infusion pump and saline infusion control motor not shown);

FIG. 2 is a schematic cross-sectional view of the rotational atherectomy interventional system of FIG. 1 with the flexible shaft and guidewire removed;

FIG. 3 is a schematic perspective view of a portion of a flexible shaft and a preferred embodiment of a rotational atherectomy head of the present invention;

FIG. 4 is a right side view of a portion of the flexible shaft and a preferred embodiment of the rotational atherectomy head of the present invention;

FIG. 5 is a front view of a portion of the flexible shaft and a preferred embodiment of the rotational atherectomy head of the present invention;

FIG. 6 is an enlarged partial schematic view of FIG. 1 at A;

FIG. 7 is a schematic view of a portion of the enlarged structure at B in FIG. 1;

FIG. 8 is an enlarged partial schematic view of FIG. 1 at C;

FIG. 9 is a schematic view of an exploded configuration of the rotational atherectomy interventional system of the present invention at the guidewire clamping system;

fig. 10 is a schematic cross-sectional view of a rotational atherectomy interventional system of the present invention at a guidewire clamping system.

The reference numbers illustrate:

Detailed Description

The present invention will be described below based on examples, but the present invention is not limited to only these examples. In the following detailed description of the present invention, certain specific details are set forth in order to avoid obscuring the nature of the present invention, well-known methods, procedures, and components have not been described in detail.

Further, those of ordinary skill in the art will appreciate that the drawings provided herein are for illustrative purposes and are not necessarily drawn to scale.

Unless the context clearly requires otherwise, throughout the description and the claims, the words "comprise", "comprising", and the like are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense; that is, what is meant is "including, but not limited to".

In the description of the present invention, it is to be understood that the terms "first," "second," and the like are used for descriptive purposes only and are not to be construed as indicating or implying relative importance. In addition, in the description of the present invention, "a plurality" means two or more unless otherwise specified.

Description of the drawings: when the invention is used with a coronary artery rotational atherectomy interventional system, one end closer to the inside of a human body is front, and the other end is back; in addition, the "housing" of the rotational atherectomy access system of the present invention is a support or shield member that is common to a plurality of components, thereby providing shielding for the components that are mounted within the housing, and the use of the term "housing" does not require that any of the components of the rotational atherectomy access system be located within the housing.

The coronary artery rotational atherectomy interventional system provided by the invention is shown in the attached drawings 1-10 and comprises a rotational atherectomy mechanism, a normal saline perfusion system, a driving and controlling system and a guide wire clamping system;

the rotational grinding mechanism comprises a guide wire 20, a driving shaft assembly and a rotational grinding head 322;

the guide wire clamping system comprises a limit switch 70 and a limit switch state detection and transmission module, the limit switch 70 is connected with the limit switch state detection and transmission module, and after the guide wire 20 is clamped, the limit switch 70 is triggered to be in a closed state and is detected by the limit switch state detection and transmission module;

the saline infusion system comprises an infusion pump (which is typically located outside the housing 10 and is not shown in the figures), an infusion pump control element connected to the infusion pump, the infusion pump control element being capable of controlling the infusion pump to be in an activated state, and an infusion pump status detection and transmission module connected to the infusion pump status detection and transmission module such that the activated state of the infusion pump is detectable by the infusion pump status detection and transmission module;

the driving and control system comprises a driving motor 50 and a controller module, and the limit switch state detection and transmission module and the infusion pump state detection and transmission module are respectively connected with the controller module so as to transmit state data to the controller module;

the controller module sends a command to start the driving motor 50 after confirming that the infusion pump of the saline perfusion system is in a started state and the limit switch is in a closed state, so that the driving motor 50 rotates, and the rotational head 322 is driven to rotate together by the driving shaft assembly.

Specifically, the guide wire 20 penetrates through the housing 10 of the rotational atherectomy interventional system, and extends from the foremost end to the rearmost end of the rotational atherectomy interventional system, the foremost end of the guide wire 20 extends out of the foremost end of the housing 10 of the rotational atherectomy interventional system, and the tail end of the guide wire 20 extends out of the rearmost end of the housing 10 of the rotational atherectomy interventional system. The guide wire 20 is a track for the sliding of the drive shaft assembly and guides the sliding of the drive shaft assembly. During the operation of the rotational atherectomy system, the guide wire 20 is used to guide the rotational atherectomy head 322 to the operating position, and the physiological saline is supplied to lower the temperature of the rotational atherectomy device during operation and prevent the blood of the living body from flowing back into the rotational atherectomy system. According to the coronary artery rotational grinding interventional system, before the driving motor 50 is started to enable the rotational grinding device to start the rotational grinding operation on plaques in blood vessels of a living body, whether an infusion pump of a saline infusion system is in a started state and whether the limit switch 70 is in a closed state are firstly confirmed, so that the extremely large injury to a human body caused by the fact that the rotational grinding operation is started under the condition that no saline is supplied or a guide wire is not clamped is avoided, the health and safety of the human body are effectively guaranteed, the fact that whether the saline can be normally supplied and the guide wire is clamped does not need to be checked by specially paying manpower, the operation convenience is obviously optimized, and the operation experience is effectively improved.

Preferably, referring to fig. 1 and 3-5, the driving shaft assembly comprises a driving shaft 30, the driving shaft comprises a rigid shaft 31 and a flexible shaft 32, the flexible shaft 32 is fixedly connected to the front side of the rigid shaft 31, the grinding head 322 is formed at one end of the flexible shaft 32 far away from the rigid shaft 31, and the grinding head 322 comprises an eccentric structure 321 surrounding the flexible shaft 32 in the circumferential direction; the eccentric structure 321 comprises a cylindrical section 321a, and in different radial directions of the cross section of the cylindrical section 321a, a straight line formed by connection between a first point, which is closest to the central axis of the flexible shaft, of the outer wall surface of the cylindrical section and a second point, which is farthest from the central axis of the flexible shaft, is intersected with the central axis of the flexible shaft; the straight-line distance H between the first point and the second point is 0.8-1.2mm, and the difference between the distance L2 from the second point to the central axis and the distance L1 from the first point to the central axis is 0.05-0.2 mm.

Preferably, the linear distance between the first point and the second point is 0.9mm, and the difference between the distance from the second point to the central axis and the distance from the first point to the central axis is 0.1 mm.

Specifically, the flexible shaft 32 is connected to the rigid shaft 31 (see fig. 7, which shows the front end of the rigid shaft 31, where the flexible shaft 32 can be connected to the rigid shaft), such as by inserting to form an interference fit, or by welding, and may include inner and outer spring wires that are disposed in a snug fit. The inner layer spring wire comprises a plurality of strands of inner layer spring wires which are spirally wound and mutually attached, the outer layer spring wire comprises a plurality of strands of outer layer spring wires which are spirally wound on the outer surface of the inner layer spring wire and mutually attached, and the spiral winding directions of the outer layer spring wires and the inner layer spring wires are opposite; and at the both ends of flexible axle, each outer spring silk passes through laser welding to be connected, and each inlayer spring silk passes through laser welding to be connected, and inlayer spring silk and outer spring silk also pass through laser welding to be connected simultaneously, promptly at the both ends of flexible axle, all weld all spring silks together, can specifically polish after the welding to make its terminal surface level, the surface is smooth.

The grinding head 322 is formed at an end of the flexible shaft 32 remote from the rigid shaft 31. The rotational head 322 includes an eccentric structure 321 surrounding the flexible shaft 32 in the circumferential direction, the eccentric structure includes a cylindrical section 321a, and the farthest distances of the outer wall surface of the cylindrical section 321a from the central axis of the flexible shaft 32 are different in different radial directions of the cross section of the cylindrical section 321 a; and the farthest distances of the outer wall surfaces of the cylindrical sections 321a from the central axis of the flexible shaft 32 in the axial direction of the flexible shaft 32 are the same.

In different radial directions of the cross section of the cylindrical section 321a, a straight line intersecting the central axis of the flexible shaft 32 may be formed between a first point, which is closest to the central axis of the flexible shaft 32, of the outer wall surface of the cylindrical section 321a and a second point, which is farthest from the central axis of the flexible shaft 32, that is, a first radial direction formed by connecting the first point and a central point of the same cross section of the flexible shaft and a second radial direction formed by connecting the second point and the central point are separated by 180 °.

The diameter of the flexible shaft 32 may be 0.5-0.8mm, preferably 0.65 mm; the linear distance between the first point and the second point may be 0.8-1.2mm, preferably 0.9 mm; the difference between the distance from the second point to the central axis and the distance from the first point to the central axis is 0.08-0.16mm, preferably 0.1 mm. The distance between the second point and the central axis of the flexible shaft 32 is slightly larger than the radius of the flexible shaft 32, because the rotational grinding head of the present invention is processed in an electroplating manner to ensure a small size, and the mold is difficult to completely cover part of the outer surface of the flexible shaft, so that the rotational grinding head is usually formed in the whole circumferential direction of the flexible shaft, and the aforementioned "distance between the second point and the central axis of the flexible shaft is slightly larger than the radius of the flexible shaft" is an unavoidable result of this processing manner.

Preferably, the rotational grinding head 322 further comprises a tapered portion 322a located at the front end of the eccentric structure 321, the tapered portion 322a is coaxial with the flexible shaft 32, the large diameter end of the tapered portion 322a is connected to the eccentric structure 321, the eccentric structure 321 further comprises a first eccentric tapered section 321b and a second eccentric tapered section 321c located at the front end and the rear end of the cylindrical section 321a, respectively, wherein the small diameter end of the first eccentric tapered section 321b is connected to the large diameter end of the tapered portion 322a, the large diameter end of the first eccentric tapered section 321b is connected to the front end of the cylindrical section 321a, the large diameter end of the second eccentric tapered section 321c is connected to the rear end of the cylindrical section 321a, and the small diameter end of the second eccentric tapered section 321c is connected to the outer circumferential surface of the flexible shaft 32; the conical part 322a is made of stainless steel, and the outer surface of the conical part is a smooth surface; the eccentric structure 321 includes an electroformed nickel substrate and abrasive particles galvanically embedded in the substrate. In another embodiment, the tapered portion 322a may not be connected to the eccentric structure 321, and may have a certain interval therebetween, and the interval length may be, for example, 5mm, 8mm, and the like.

The cylindrical section 321a may extend 0.8-1.5mm, preferably 1mm, in the axial direction of the flexible shaft. The first eccentric conical section 321b and the second eccentric conical section 321c are integrally formed with the cylindrical section 321a, and then are formed by grinding to form the first eccentric conical section 321b and the second eccentric conical section 321 c. The length of each eccentric cone section may be 0.1-0.3mm, preferably 0.2 mm. By arranging the eccentric cone section and the conical part, a vertical step is not formed between the rotational head 322 and the flexible shaft 32, so that the rotational head can conveniently enter the plaque to be rotationally ground in the blood vessel and smoothly push a part of the plaque to the outer wall surface of the rotational head to be rotationally ground.

The extension length of the conical part 322a is 0.6-1.0mm, preferably 0.8 mm; the diameter of the front end surface of the tapered part 322a is 0.35-0.6 mm. Preferably, the axial dimension of the tapered portion 322a accounts for 30% -40% of the axial dimension of the rotational head 322, the axial dimension of the cylindrical section 321a accounts for 40% -50% of the axial dimension of the rotational head 322, and the ratio of the diameter of the cylindrical section 321a to the axial dimension of the eccentric structure 321 is 0.6-0.7.

Because the radial dimension of the conical head 322a is smaller relative to the radial dimension of both the cylindrical section 321a and the eccentric conical section, the provision of the conical portion 322a further facilitates pushing a portion of the plaque onto the outer wall surface of the rotational head for rotational grinding.

Compared with other rotary grinding heads in the prior art, the rotary grinding head provided by the invention has the advantages that the size in the radial direction of the flexible shaft can be smaller, the volume of the whole rotary grinding head is smaller, and therefore, even if the plaque is larger, the rotary grinding head can easily reach the center of the plaque, and meanwhile, the excellent cutting effect can be still ensured. Furthermore, in the operation process, because whole rotary grinding head is little in flexible axle radial direction size, so volume and quality are less, when rotary grinding head is rotating around the axis of axle subassembly, rotary grinding head's rotation can drive the blood motion around, the fluid pressure field that forms by the blood motion can promote rotary grinding head and make circumferential direction around the blood vessel inner wall, when rotary grinding head is around self axis rotation promptly, still can revolute around the circumference of blood vessel inner wall, along with the plaque by the grinding volume grow more and more, the diameter in blood vessel inner cavity space also grows more and more, rotary grinding head orbital diameter also grows gradually, thereby carry out the grinding gradually to the plaque.

According to the rotary grinding head structure form, the rotary grinding head grinds the plaque in the circumferential direction of the blood vessel along with the revolution of the rotary grinding head, and does not grind a certain position in the circumferential direction of the blood vessel all the time, so that the blood temperature rise caused by grinding can be reduced as far as possible. In addition, although the driving shaft rotates at a high speed, the grinding force is relatively small compared with a large-diameter rotary grinding head because the rotary grinding head rotates and revolves simultaneously and the volume and the mass of the rotary grinding head are relatively small, the amplitude can be reduced by more than 5%, and the impact on blood vessels is reduced. In addition, the flexible shaft is arranged into a reversely surrounding double-layer structure, so that when the flexible shaft rotates reversely, the spring wires on the inner layer and the outer layer interact with each other, and the flexible shaft can be well prevented from loosening; and adopt this kind of double-deck reverse structure, structure that surrounds more than the three-layer relatively can enough improve the pliability of flexible axle, can guarantee the transmission of moment of torsion again, and the diameter of whole flexible axle also can not too big, is favorable to the motion in the blood vessel. Furthermore, the two ends of the flexible shaft are respectively connected by laser welding, so that the spring wires at the two ends are integrated, the looseness of the inner layer, the outer layer and each layer of spring wires caused by the high-speed rotation and the reverse rotation of the flexible shaft can be avoided as much as possible, a protective sleeve at the end part of the flexible shaft is omitted, the reliability of the driving shaft is improved, and the assembly efficiency of the whole coronary artery rotational grinding intervention system is improved; simultaneously the head of grinding soon can set up at the tip of flexible shaft, and when the flexible shaft and the initial stage of plaque contact, because the grinding effect of the head of grinding soon, can reduce the contact force between flexible shaft and the plaque, reduce the impact of flexible shaft to the blood vessel, otherwise, if the head of grinding soon leaves the distance with the tip of flexible shaft, then when the tip of flexible shaft touches the plaque, it is bigger to the impact of blood vessel.

Preferably, after the infusion pump control element controls the infusion pump to be started, the infusion pump status detection and transmission module sends a first indication signal to the controller module to enable the controller module to confirm that the infusion pump is in a started state.

Signal transmission is usually in the electromagnetic wave form, there is mutual interference easily between the different electromagnetic waves, this application is through setting up the opto-coupler between transfer pump state transmission module and controller module, can realize the one-way transmission of signal through the opto-coupler processing, make between input and the output realized electrical isolation completely, output signal does not have the influence to the input, can not disturb first instruction signal promptly, make controller module can accurately discern first instruction signal, it is strong to have accomplished the interference killing feature, the operation is stable, and is contactless, long service life, and high transmission efficiency.

Specifically, the limit switch and the limit switch state detection and transmission module may be integrated in the same displacement sensor, and when the guide wire is clamped, the displacement sensor (the limit switch state detection and transmission module inside) sends a second indication signal to the controller module.

The coronary artery rotational atherectomy intervention system provided by the invention can realize the feedback control of the rotating speed of the driving motor, and can return to the standard rotating speed when the speed of the driving motor is larger or smaller. Specifically, there is speed check out test set in speed check out test set, for example, hall sensor, can measure motor speed in real time through hall sensor, when motor speed is greater than or less than preset speed, the PWM pulse that its self sent can be adjusted to the controller module, after motor drive module received aforementioned pulse, and then adjust driving motor's rotational speed to predetermineeing speed (for example, the rotational speed of motor is adjusted to the electric current that the accessible increased and decreased motor), driving motor's rotational speed feedback control has been realized, whole motor speed regulation process can be realized through PID control mode is automatic.

Preferably, drive and control system still includes display screen 60, many gears knob switch 61, gear information processing module and motor drive module, many gears knob switch connect gear information processing module, gear information processing module connects the controller module, the controller module is connected motor drive module, motor drive module connects driving motor 50 is on the gear selected with control driving motor 50's rotational speed, display screen 60 sets to become 30 degrees contained angles with the horizontal plane for show driving motor's rotational speed and grind time soon.

For the rotation speed of the driving motor of the rotational atherectomy interventional system, there are a plurality of gear positions that can be selected, i.e., the driving motor 50 can be set to rotate at different standard rotation speeds. Specifically, after the multi-gear knob switch 61 is rotated to a selected gear by an operator, the selected gear can output specific coded information corresponding to the selected gear (that is, different coded information is output corresponding to different selected gears), after receiving the coded information, the gear information processing module compares the coded information with the corresponding relationship between the coded information stored in the gear information processing module and the gear, and then determines which gear is selected, and the controller module connected to the gear information processing module can control the motor driving module to adjust the motor speed to the speed value corresponding to the gear.

Preferably, drive and control system still includes sampling resistance, sampling resistance voltage acquisition module, amplifier, enlarged voltage information transmission module and motor drive module, driving motor connects sampling resistance, sampling resistance connects sampling resistance voltage acquisition module, sampling resistance voltage acquisition module connects the amplifier, enlarged voltage information transmission module is connected to the amplifier, enlarged voltage information transmission module connects the controller module, the controller module is connected the motor drive module, the motor drive module is connected driving motor 50, when the overload takes place, controller module control the motor drive module stops the drive driving motor 50, makes driving motor stall.

The rotational atherectomy interventional system has an overload protection function and is realized by the technical scheme. The circuit of the driving and control system is provided with a sampling resistor which is connected in series, the resistance value of the sampling resistor can be small, such as 50 milliohms and the like, so that the influence on the original circuit is reduced as much as possible, and the voltage at two ends of the sampling resistor is not easy to accurately measure. When an overload condition occurs, the controller module controls the motor driving module to stop driving the driving motor 50, so that the driving motor 50 stops rotating, and the overload protection function is realized.

Preferably, the drive and control system further comprises a motor drive module; the saline perfusion system further includes a plurality of flow rate adjusting circuits and a saline perfusion control motor (which is usually located outside the housing 10 and not shown in the figure), the plurality of flow rate adjusting circuits include a plurality of resistors and a plurality of flow rate selection switches, the resistors have different resistance values, the flow rate adjusting circuits, the flow rate selection switches and the resistors have the same number, one flow rate selection switch and one resistor are connected in series in the same flow rate adjusting circuit, and each flow rate adjusting circuit is connected to the controller module; the controller module is connected with the normal saline perfusion control motor, controls the rotating speed of the normal saline perfusion control motor and further controls the perfusion speed of the normal saline.

The normal saline has at least two flow rates, wherein one flow rate is a common flushing speed, which means that the flow rate of the normal saline is the common flushing speed when a rotary-grinding head of the coronary rotary-grinding interventional system is in the human body but is not in a state of rotating at a high speed to grind plaques in a rotary-grinding mode, and the normal saline is flushed at the common flushing speed uninterruptedly so as to prevent blood from flowing back into the coronary rotary-grinding interventional system; the other flow rate is a high-speed perfusion rate, which means that the flow rate of the physiological saline is a high-speed perfusion rate higher than a normal flushing rate in a state that the rotational head rotates at a high speed inside a human body to rotationally grind plaques, so that the rotational head is sufficiently cooled while preventing blood from flowing backwards. In order to enable the physiological saline to work at least two different flow rates, a plurality of flow rate adjusting circuits (at least two) are arranged in the physiological saline control system, each flow rate adjusting circuit comprises a flow rate selection switch and a resistor, and the different flow rate adjusting circuits are in different access states through the on-off of the flow rate selection switch, so that currents are different in different accesses due to the difference of resistance values of the resistors, the controller module can judge the flow rate corresponding to the current signal and selected by an operator according to the received different current signals, and the rotating speed of the motor is controlled by controlling the filling of the physiological saline, so that the filling speed of the physiological saline is controlled.

Preferably, the stiffness of the guidewire 20 is less than the stiffness of the flexible shaft 32 to enable the guidewire 20 to better conform to the extended path of the blood vessel.

In order to reduce the damage to blood vessels, the rotating speed of the driving shaft can reach a high rotating speed of 17-25 ten thousand revolutions per minute, but the high rotating speed is generally only used in the rotational grinding state of the coronary artery rotational grinding interventional system, and the rotating speed is set to be lower in the non-rotational grinding state. Of course, the rotation speed of 17-25 ten thousand revolutions per minute is not used in the spin-grinding state, but a lower rotation speed, such as 7000 revolutions per minute, 9000 revolutions per minute, etc., may be set.

Wherein, the spiral surrounding direction of the outer layer spring wire in the flexible shaft 32 and the rotation direction of the driving shaft in the driving motor 50 can be the same or opposite, in a preferred embodiment, the spiral surrounding direction of the outer layer spring wire is the same as the rotation direction of the driving shaft of the driving motor in a grinding state, so that the flexible shaft can be in a winding state better during grinding operation, torque can be transmitted better, and the grinding speed can be further improved.

When the flexible shaft 32 rotates at a high speed, friction may occur between the flexible shaft 32 and the guide wire 20 inserted therein, and in order to reduce wear of the flexible shaft 32 and the guide wire 20, the inner surface of the flexible shaft 32 and the outer surface of the guide wire 20 may be respectively provided with an anti-friction coating, which may be formed on the inner surface of the flexible shaft 32 and the outer surface of the guide wire 20 by surface treatment or spraying. The friction reducing coating may be a polytetrafluoroethylene coating.

Preferably, the drive shaft assembly includes a drive shaft 30 and a drive shaft sleeve; the drive and control system further comprises a drive gear and a transmission gear, a portion of the drive shaft 30 is fixedly mounted to the transmission gear, at least a portion of the drive shaft that is not fixedly mounted to the remainder of the transmission gear, and at least a portion of the guide wire are located within the drive shaft sleeve; the driving shaft sleeve comprises a front side sleeve and a rear side sleeve, the front side sleeve comprises a front side movable rail pipe 41 and a front side static rail pipe 42 which are arranged in a nested manner, and the front side sleeve is positioned in front of the transmission gear; the rear sleeve comprises a rear movable rail pipe 43 and a rear static rail pipe 44 which are arranged in a nested mode, and the rear sleeve is located behind the transmission gear.

Preferably, there is a first friction reducing tube (not shown) between the drive shaft 30 and the front side moving rail tube 41.

Preferably, there is a second friction reducing tube (not shown) between the drive shaft 30 and the rear side moving rail tube 43.

Preferably, a wear reducing coating is provided on at least a portion of the outer surface of the drive shaft 30.

Preferably, a flexible sealing ring 45 is arranged outside the front movable rail pipe, and the inner diameter of the sealing ring is smaller than the outer diameter of the front movable rail pipe in a natural state; and a flexible sealing ring 45 is arranged outside the rear movable rail pipe, and the inner diameter of the sealing ring is smaller than the outer diameter of the rear movable rail pipe in a natural state.

Specifically, the rigid shaft 31 of the driving shaft 30 is inserted into the transmission gear, so that a portion of the driving shaft is fixedly mounted on the transmission gear and is in interference fit with the transmission gear to transmit the driving power of the driving motor to the rigid shaft 31, and the axial direction of the rigid shaft is parallel to the sliding direction of the driving mechanism, specifically, the axial direction of the driving shaft of the driving motor and the revolving shaft of the transmission gear.

As will be appreciated by those skilled in the art, the drive shaft 30 is a hollow shaft and the guide wire 20 extends through the drive shaft 30. And with the forward sliding of the driving mechanism, the driving shaft 30 slides forward relative to the housing 10, but may bend or otherwise fail during movement, and cannot slide along a predetermined direction, increasing the difficulty of manipulation, while in the process of pulling back the driving shaft, the driving shaft and the guide wire may also bend, thereby preventing the driving shaft from retracting. Referring to fig. 2, 6 and 7, a rigid shaft 31 portion of the driving shaft 30 is inserted with interference at the driving gear below the driving motor, while a driving shaft portion located in front of the driving gear is disposed in the front side sleeve, and a driving shaft portion located behind the driving gear and the guide wire are disposed in the rear side sleeve. The front side sleeve and the rear side sleeve are arranged along the axial direction of a driving shaft at the position of a transmission gear, the front side sleeve is positioned in front of the transmission gear, the rear side sleeve is positioned behind the transmission gear, sleeve supporting seats are arranged at intervals on the bottom wall of the shell and support the front side sleeve and the rear side sleeve to extend along the axial direction.

The front side sleeve comprises a front side movable rail pipe 41 and a front side fixed rail pipe 42 which are nested to form a sliding pair. In the present embodiment, the front movable rail pipe 41 is provided inside the front stationary rail pipe 42. The portion of the drive shaft in front of the drive gear is fitted into the inner cavity of the front side rail tube in a fixed manner relative to the front side rail tube 41. There is a first friction reducing tube between the drive shaft and the front side moving rail tube 41 to reduce the friction between the two.

The rear sleeve comprises a rear movable rail pipe 43 and a rear stationary rail pipe 44, which are nested to form a sliding pair, in this embodiment, the rear movable rail pipe 43 is arranged inside the rear stationary rail pipe 44. The portion of the drive shaft behind the transmission gear is fitted in the inner cavity of the rear side rail tube in a manner fixed relative to the rear side rail tube 43. A second friction reducing tube is provided between the drive shaft and the rear side moving rail tube 43 to reduce the friction therebetween.

Friction between components adjacent the drive shaft as the drive shaft moves relative to each other may also be reduced by providing a friction reducing coating on at least a portion of the outer surface of the drive shaft.

The coronary artery rotational grinding interventional system is internally provided with the sliding groove, the front side movable rail pipe 41 and the rear side movable rail pipe 43 can slide along the sliding groove, and the driving shaft is ensured to be smoothly pushed and retracted along the axial direction, so that the rotational grinding head is delivered to a plaque to be rotationally ground, and the rotational grinding head is retracted after the rotational grinding is finished, and the safety and the reliability of the plaque rotational grinding excision operation are effectively ensured.

It can be understood by those skilled in the art that, under the condition of the same pipe wall thickness, the outer diameters of the movable rail pipes on both sides and the stationary rail pipes on both sides are larger than the outer diameter of the driving shaft, so the bending strength of the movable rail pipes on both sides and the stationary rail pipes on both sides is larger than the bending strength of the driving shaft, and because the movable rail pipes on both sides and the stationary rail pipes on both sides are not used for extending into the interior of the blood vessel of the human body, and according to the purpose of the present invention, the requirement is opposite to easy bending, and the movable rail pipes on both sides and the stationary rail pipes on both sides require sufficiently high bending strength, so that the movable rail pipes on both sides and the stationary rail pipes on both sides can be made of materials with higher strength, such as 304 stainless steel, under the condition that the pipe wall thickness is smaller than or equal to the driving shaft pipe wall.

The first friction reducing pipe/the second friction reducing pipe can be made of medical polyimide materials, and has the advantages of low surface friction coefficient and high temperature resistance. When reducing the frictional force when relative slip, can also fill the clearance between drive shaft and front side moving rail pipe/rear side moving rail pipe through the setting of first antifriction pipe/second antifriction pipe, reduced the rate that spills normal saline backward from the normal saline perfusion system that is located front side moving rail pipe the place ahead.

Through the sheathed tube setting of drive shaft, the axial guide effect has been strengthened, and the quiet rail pipe of front side can also play the restraint effect to the drive shaft of radial inboard side to the movable rail pipe of front side or the quiet rail pipe of front side, prevents that the drive shaft from excessively buckling, and the quiet rail pipe of rear side can retrain seal wire and drive shaft simultaneously along radial to guarantee that axial thrust transmits smoothly to the bistrique of locating the drive shaft distal end, guarantee promptly that the drive shaft advances smoothly along the axial and back, and then guarantee to grind the security of excision operation soon.

As already described, the rotational atherectomy interventional system has a saline perfusion system. The saline solution infused through the system eventually enters the drive shaft sleeve assembly and flows along the cavity inside the drive shaft sleeve assembly, reducing the temperature of the drive shaft 30 located inside the drive shaft sleeve, particularly the temperature of the atherectomy head 322 on the flexible shaft 32 portion of the drive shaft 30. By arranging the flexible sealing ring 45 outside the front movable rail pipe, the inner diameter of the sealing ring 45 is smaller than the outer diameter of the front movable rail pipe 41 in a natural state; the flexible sealing ring 45 is arranged outside the rear moving rail pipe 43, and in a natural state, because the inner diameter of the sealing ring 45 is smaller than the outer diameter of the rear moving rail pipe 43, the leakage of the physiological saline can be effectively reduced, the physiological saline only flows to the tail end of an interventional catheter described below in the driving shaft sleeve assembly to flow out as much as possible, and the physiological saline is prevented from leaking in the shell of the coronary rotational atherectomy interventional system, so that the normal work of the coronary rotational atherectomy interventional system is influenced.

Preferably, referring to fig. 9-10, the limit switch 70 is fixed opposite to and extends beyond the back wall of the housing 10 of the rotational atherectomy interventional system; the guide wire clamping system comprises a multi-jaw chuck 73, a chuck cover 71 and a chuck cover fixing seat 72, wherein the multi-jaw chuck 73 comprises a chuck part 731 formed by a plurality of mutually independent jaws and a main body part 732 used for fixedly connecting the plurality of mutually independent jaws, the main body part 732 is arranged in the chuck cover 71, and the chuck part 731 extends into the chuck cover fixing seat 72; the clip cover fixing seat 72 is fixed to the rear wall, a portion of the clip cover fixing seat 72 behind the rear wall has an external thread, a rear opening 721 of the clip cover fixing seat 72 is used for the insertion of the clip part 731, and the rear opening 721 includes a tapered multi-jaw clip clamping part 721a therein; the inner part of the chuck cover 71 is provided with an internal thread matched with the external thread, and the chuck cover 71 is fixed on the chuck cover fixing seat 72 through the matching of the internal thread and the external thread; the multi-jaw chuck 73 has elasticity, the chuck part 731 of the multi-jaw chuck 73 can be expanded accordingly after the guide wire 20 is inserted into the multi-jaw chuck 73, and after the chuck cover 71 is screwed to the chuck cover fixing base 72, an interference fit can be formed between the multi-jaw chuck clamping part 721a and the expanded chuck part 731, and the interference fit clamps the chuck part 731, so that the guide wire 20 is clamped by the multi-jaw chuck 73; after the chuck cover 71 is screwed to the chuck cover fixing seat 72, the front end surface of the chuck cover 71 can press the limit switch 70 to trigger the limit switch 70 to be in a closed state.

Specifically, the multi-jaw chuck is, for example, a four-jaw chuck or a three-jaw chuck, and may be shaped like a cross half-head bolt, where an opening is formed in the interior of the four-jaw chuck from the rear end surface to the front, the opening extends to the interior of the bolt head, the bolt head is provided with a cross-shaped slit, the cross-shaped slit extends in the radial direction up to the radial outer edge of the bolt head, the cross-shaped slit further extends in the length direction up to the body portion of the bolt (the body portion of the bolt does not include the bolt head), but does not penetrate through the body portion of the bolt, so as to form a four-jaw chuck, where the front end includes four jaws and the four jaws are sequentially arranged in the circumferential direction, and at this time, the four independent jaws form a chuck portion, and a portion located behind the four independent jaws is a main body portion of the multi-jaw chuck.

Upon tightening of the clip cover 71 relative to the clip cover retainer 72, two results occur, the first being that as a result of the aforementioned tightening, the multi-jaw clip 73 is pushed forward into the multi-jaw clip gripping portion 721a, which is tapered on its inner surface, so that an interference fit is formed between the multi-jaw clip gripping portion 721a and the flared clip portion 731, which interference fit clamps the clip portion 731, thereby causing the wire 20 clamped within the clip portion 731 to be gripped by the multi-jaw clip 73; secondly, due to the aforementioned screwing, the front end surface of the cartridge cover 71 changes from being unable to contact the rear end surface of the limit switch 70 to being able to contact and press the rear end surface of the limit switch 70, thereby triggering the limit switch 70 to be in a closed state (for example, two compression springs that are not originally in contact with each other may be arranged in the limit switch of an embodiment, since the two compression springs are pressed to be in contact with each other after the limit switch is pressed by the front end surface of the cartridge cover, that is, the limit switch is closed, the contact of the two compression springs constitutes a circuit path, and the closed state of the limit switch can be detected by the limit switch detection and transmission module).

Preferably, the cartridge cover 71 includes a first stopping structure 711 having a cylindrical shape, and a second stopping structure 75 is further disposed inside the cartridge cover 71, and after the cartridge cover 71 is screwed with respect to the cartridge cover fixing seat 72, the first stopping structure 711 and the second stopping structure 75 can stop the multi-jaw cartridge 73 from moving backwards.

The first stop structure 711 may be a cylindrical structure inside the collet cap, which may be formed integrally with the collet cap, and the inside diameter of the cylinder is slightly larger than the outside diameter of the body portion of the cross-like half-headed bolt, but smaller than the diameter of the bottom of the bolt head thereof, whereby, after the collet cap is tightened with respect to the collet cap holder, the body portion of the bolt is located inside the cylinder, and the front end surface of the cylinder abuts against the bottom of the bolt head due to the aforementioned tightening, blocking the rearward movement of the multi-jaw collet.

The second stopping structure 75 may be located behind the multi-jaw chuck 73, a front end surface of the second stopping structure 75 abuts against a rear end surface of the multi-jaw chuck 73, and the rear end surface of the second stopping structure 75 is directly or indirectly limited by the chuck cover 71, so that the second stopping structure 75 can also stop the multi-jaw chuck 73 from moving backwards. The second stopper structure 75 is provided with a through hole therein, the through hole may include a flare hole portion and an equal diameter hole portion, the flare hole portion is closer to the rear end face of the multi-jaw chuck 73 than the equal diameter hole portion, the diameter of the equal diameter hole portion is equal to the diameter of the rear end of the flare hole portion, so that a guiding effect can be provided for the guide wire to smoothly pass through the through hole inside the second stopper structure.

Preferably, the guide wire clamping system further comprises a flexible sealing structure 74, the flexible sealing structure 74 has a first through hole 741 for the guide wire to pass through, in a natural state, the diameter of the first through hole 741 is not greater than the diameter of the guide wire 20, the flexible sealing structure 74 is located inside the clip cover 71 and behind the second stop structure 75, and a front end face of the flexible sealing structure 74 abuts against a rear end face of the second stop structure 75.

The flexible sealing structure 74 may be made of silicone, and it is understood that the diameter of the first through hole 741 is not larger than the outer diameter of the guide wire 20, but allows the guide wire 20 to pass therethrough, after the clip cover 71 is screwed with respect to the clip cover fixing seat 72, the flexible sealing structure 74 is compressed and deformed, further compressing the guide wire 20, and the gap between the guide wire 20 and the flexible sealing structure 74 is further reduced, so as to perform a sealing function, and prevent the physiological saline (if any) leaking from the driving shaft sleeve into the housing of the coronary artery rotational atherectomy interventional system from flowing out of the coronary artery rotational interventional system through the first through hole 741 between the guide wire 20 and the flexible sealing structure 74.

Through the specific arrangement of the upper guide wire clamping system, the guide wire can be effectively clamped, and medical accidents caused by the displacement of the guide wire in the working process of a coronary artery rotational abrasion intervention system are avoided.

The coronary artery rotational atherectomy intervention system further comprises an intervention catheter mechanism, wherein one part of the intervention catheter mechanism is positioned inside the shell, and the other part of the intervention catheter mechanism extends out of the front end of the shell. The housing comprises a front wall and a bottom wall in addition to the above mentioned rear wall, and the front wall is provided with a second through hole 11.

Intervene pipe mechanism including intervene pipe 80 and adaptor 90, a part of drive shaft is located intervene inside the pipe, adaptor 90 is inside to be equipped with the adaptor through-hole, intervene the rear end of pipe 80 insert inside the adaptor through-hole, with adaptor through-hole interference fit.

The adapter 90 includes an adapter front portion 91, an adapter reducing structure 92, and an adapter rear portion 93. The front part 91 of the adapter is exposed out of the shell 10, the front part 91 of the adapter is a cone made of flexible materials, the structure is attractive, the protection is convenient, and the interventional catheter 80 is not easy to bend due to stress. The adapter reducing structure 92 is located between the adapter front portion 91 and the adapter rear portion 93, and the minimum diameter of the adapter reducing structure 92 is smaller than the minimum diameter of the adapter front portion 91 and the minimum diameter of the adapter rear portion 93. The second through hole 11 on the front end surface of the housing 10 is matched with the size of the reducing structure 92, so that the reducing structure 92 can be clamped at the second through hole 11, and the adaptor 90 is fixed on the housing 10.

The saline solution filling system further includes an output connector 100 and a water inlet pipeline (not shown in the figure), wherein the end of the water inlet pipeline is inserted into the side wall of the output connector 100 to form an interference fit, so that the water inlet pipeline is reliably fixed, and the leakage of the saline solution at the position is avoided as much as possible.

Further, the rear end of the interventional catheter 80 can also completely pass through the through hole inside the adaptor 90 until reaching the inside of the output connector 100 of the saline perfusion system. Therefore, the low-temperature physiological saline can quickly enter the interventional catheter 80 after entering the output connector 100 from the water inlet pipeline, and then enters the blood vessel of the human body along the interventional catheter 80, so that the rotating and grinding head 322 in the cooling working state is realized. Further, the interior of the rear portion of the adaptor and the exterior of the front end of the output connector are provided with a first snap-fit structure so that both adaptor 90 and output connector 100 can be secured together.

The first clamping matching structure comprises a clamping connector 102 and a clamping groove, the clamping groove is formed in the rear portion 93 of the adapter, and the clamping connector 102 is arranged at the front end of the output connector 100 and matched with the clamping groove. In order to facilitate the installation of the clamping connector 102 into the clamping groove, a chamfer is arranged at the junction of the front end surface and the side wall of the output connector 100, and the angle of the chamfer can be 30-60 degrees.

The output connector 100 includes an output connector body 101 and a latch 102, and the latch 102 is located at the front of the output connector body 101. The output joint main body part 101 comprises an output joint front part 103, an output joint reducing part 104 and an output joint rear part 105, wherein a first slope transition section is arranged between the output joint reducing part 104 and the output joint front part 103, and a second slope transition section is arranged between the output joint reducing part 104 and the output joint rear part 105. The output connector is internally provided with a through hole which can be variable-diameter, the part of the through hole, which is contacted with the intervention conduit, can be in interference fit to clamp the tail end of the intervention conduit, and the part of the through hole, which is contacted with the front side static rail pipe described below, can also be in interference fit to clamp the front end of the front side static rail pipe.

The upper surface of the bottom wall of the shell of the coronary artery rotational atherectomy intervention system is provided with an output joint bearing seat, and the output joint bearing seat is used for supporting the front part of the output joint.

In the coronary artery rotational atherectomy interventional system, the display screen of the driving and control system can display the temperature of the rotational atherectomy head besides displaying the real-time rotating speed of the driving motor, the current rotating time, the accumulated rotating time and the like. The display screen and the multi-gear selection knob are arranged at the rear end of the device (behind the physiological saline perfusion system and behind the drive motor), so that the main surgeon is mainly responsible for operating the instrument and observing the CT imaging result in the operation process based on the ergonomic consideration, the observation of the display screen and the operation knob is finished by the assistant, and the display screen and the knob are arranged at the rear end, so that the assistant can conveniently stand at the tail end of the machine and cooperate with the main surgeon to operate.

It will be appreciated by those skilled in the art that the above-described preferred embodiments may be freely combined, superimposed, without conflict.

It will be understood that the embodiments described above are illustrative only and not restrictive, and that various obvious and equivalent modifications and substitutions for details described herein may be made by those skilled in the art without departing from the basic principles of the invention.

Claims

1. A rotational grinding interventional system for coronary artery comprises a rotational grinding mechanism, a normal saline perfusion system, a driving and controlling system and a guide wire clamping system;

the method is characterized in that:

the controller module sends a command for starting the driving motor after confirming that an infusion pump of the normal saline perfusion system is in a starting state and the limit switch is in a closing state, so that the driving motor rotates, and the rotary grinding head is driven to rotate by the driving shaft assembly;

the drive shaft assembly comprises a drive shaft, the drive shaft comprises a rigid shaft and a flexible shaft, the flexible shaft is fixedly connected to the front side of the rigid shaft, the rotating head is formed at one end of the flexible shaft far away from the rigid shaft, and the rotating head comprises an eccentric structure surrounding the flexible shaft in the circumferential direction; the eccentric structure comprises a cylindrical section; the rotating head further comprises a conical part positioned at the front end of the eccentric structure, the conical part is coaxial with the flexible shaft, the large-diameter end of the conical part is connected with the eccentric structure, the eccentric structure further comprises a first eccentric conical section and a second eccentric conical section which are respectively positioned at the front end and the rear end of the cylindrical section, the small-diameter end of the first eccentric conical section is connected with the large-diameter end of the conical part, the large-diameter end of the first eccentric conical section is connected with the front end of the cylindrical section, the large-diameter end of the second eccentric conical section is connected with the rear end of the cylindrical section, the small-diameter end of the second eccentric conical section is connected with the outer circumferential surface of the flexible shaft, a vertical step does not exist between the rotating head and the flexible shaft, and the first eccentric conical section and the second eccentric conical section are integrally formed with the cylindrical section;

the limit switch is relatively fixed with the back wall of the shell of the coronary artery rotational atherectomy intervention system and extends out of the back wall;

2. The rotational atherectomy access system of claim 1, wherein, in different radial directions of the cross-section of the cylindrical section, a line connecting a first point of the outer wall surface of the cylindrical section, which is closest to the central axis of the flexible shaft, and a second point of the outer wall surface of the cylindrical section, which is farthest from the central axis of the flexible shaft, intersects the central axis of the flexible shaft; the straight-line distance between the first point and the second point is 0.8-1.2mm, and the difference between the distance from the second point to the central axis and the distance from the first point to the central axis is 0.05-0.2 mm.

3. The rotational atherectomy access system of claim 2, wherein the linear distance between the first point and the second point is 0.9mm, and the difference between the distance from the second point to the central axis and the distance from the first point to the central axis is 0.1 mm.

4. The rotational atherectomy access system of claim 3, wherein the tapered section is stainless steel and has a smooth outer surface; the eccentric structure comprises an electroformed nickel substrate and abrasive particles galvanically embedded in the substrate.

5. The rotational atherectomy access system of claim 4, wherein the axial dimension of the tapered section is between 30% and 40% of the axial dimension of the rotational atherectomy head, the axial dimension of the cylindrical section is between 40% and 50% of the axial dimension of the rotational atherectomy head, and the ratio of the diameter of the cylindrical section to the axial dimension of the eccentric is between 0.6 and 0.7.

6. The rotational atherectomy access system of any one of claims 1-5, wherein the infusion pump control element controls the infusion pump to be activated after the infusion pump status detection and transmission module issues a first indicator signal to the controller module to enable the controller module to confirm that the infusion pump is in an activated state.

7. The rotational atherectomy interventional system of claim 6, wherein the drive and control system further comprises an opto-coupler, the opto-coupler being disposed between the infusion pump status detection and transmission module and the controller module, the opto-coupler receiving the first indication signal and processing the first indication signal for transmission to the controller module.

8. The rotational atherectomy access system of any of claims 1-5, wherein the limit switch state detection and transmission module sends a second indication signal to the controller module after the limit switch is closed to enable the controller module to confirm that the limit switch is in the closed state.

9. The rotational atherectomy intervention system of any of claims 1-5, wherein the drive and control system further comprises a motor drive module and a speed detection module, the controller module is coupled to both the motor drive module and the speed detection module, the drive motor is coupled to both the motor drive module and the speed detection module, the motor drive module drives the drive motor under control of the controller module, and the speed detection module feeds real-time speed information of the drive motor back to the controller module; when the real-time measured motor rotating speed is greater than or less than the preset speed, a controller module in the control system controls the motor driving module to adjust the rotating speed of the driving motor to the preset speed.

10. The rotational atherectomy interventional system according to any one of claims 1 to 5, wherein the drive and control system further comprises a display screen, a multi-gear knob switch, a gear information processing module and a motor drive module, the multi-gear knob switch is connected with the gear information processing module, the gear information processing module is connected with the controller module, the controller module is connected with the motor drive module, the motor drive module is connected with the drive motor to control the rotational speed of the drive motor to be at a selected gear, and the display screen is arranged to form an angle of 30 degrees with the horizontal plane for displaying the rotational speed and the rotational atherectomy time of the drive motor.

11. The rotational atherectomy interventional system of any one of claims 1-5, it is characterized in that the driving and control system also comprises a sampling resistor, a sampling resistor voltage acquisition module, an amplifier, an amplified voltage information transmission module and a motor driving module, the driving motor is connected with a sampling resistor, the sampling resistor is connected with the sampling resistor voltage acquisition module, the sampling resistance voltage acquisition module is connected with an amplifier, the amplifier is connected with an amplified voltage information transmission module, the amplified voltage information transmission module is connected with the controller module, the controller module is connected with the motor driving module, the motor driving module is connected with the driving motor, when overload occurs, the controller module controls the motor driving module to stop driving the driving motor, so that the driving motor stops running.

12. The rotational atherectomy interventional system of any one of claims 1-5, wherein the drive and control system further comprises a motor drive module; the physiological saline perfusion system also comprises a plurality of flow rate regulating circuits and a physiological saline perfusion control motor, wherein the flow rate regulating circuits comprise a plurality of resistors and a plurality of flow rate selection switches, the resistance values of the resistors are different from each other, the flow rate regulating circuits, the flow rate selection switches and the resistors are the same in number, one flow rate selection switch and one resistor are connected in series in the same flow rate regulating circuit, and each flow rate regulating circuit is connected with the controller module; the controller module is connected with the normal saline perfusion control motor, controls the rotating speed of the normal saline perfusion control motor and further controls the perfusion speed of the normal saline.

13. The rotational atherectomy intervention system of claim 12, wherein the saline perfusion control motor drives the infusion pump, and the infusion pump is rotated faster or slower as the rotational speed of the saline perfusion control motor is increased or decreased, and the saline perfusion speed is increased or decreased as the rotational speed of the infusion pump changes, thereby controlling the saline perfusion speed.

14. The rotational atherectomy access system of claim 1, wherein the drive shaft assembly comprises a drive shaft and a drive shaft sleeve; the driving and control system further comprises a driving gear and a transmission gear, one part of the driving shaft is fixedly arranged on the transmission gear, at least one part of the driving shaft which is not fixedly arranged in the rest part of the transmission gear and at least one part of the guide wire are positioned in the driving shaft sleeve; the driving shaft sleeve comprises a front side sleeve and a rear side sleeve, the front side sleeve comprises a front side movable rail pipe and a front side fixed rail pipe which are nested, and the front side sleeve is positioned in front of the transmission gear; the rear side sleeve comprises a rear side movable rail pipe and a rear side fixed rail pipe which are nested, and the rear side sleeve is positioned behind the transmission gear;

15. The rotational atherectomy access system of claim 14, wherein a flexible sealing ring is disposed on the exterior of the anterior track tube, wherein the sealing ring has an inner diameter that is smaller than an outer diameter of the anterior track tube in a natural state; and a flexible sealing ring is arranged outside the rear movable rail pipe, and the inner diameter of the sealing ring is smaller than the outer diameter of the rear movable rail pipe in a natural state.

16. The rotational atherectomy access system of claim 1, wherein the cartridge cover comprises a first cylindrical stop structure, and wherein a second stop structure is disposed within the cartridge cover, the first and second stop structures being adapted to stop the multi-jaw cartridge from moving rearwardly after the cartridge cover is tightened against the cartridge cover holder.

17. The rotational atherectomy access system of claim 16, wherein the guidewire clamping system further comprises a flexible sealing structure having a first through hole for a guidewire to pass through, wherein the diameter of the first through hole is not larger than the diameter of the guidewire in a natural state, wherein the flexible sealing structure is located inside the collet cover and behind the second stop structure, and wherein a front end surface of the flexible sealing structure abuts against a rear end surface of the second stop structure.

18. The rotational atherectomy interventional system of claim 1, wherein the drive and control system further comprises a timing module and an alarm device connected to the controller module, the timing module being configured to time the rotation of the drive motor, and the controller module controlling the alarm device to issue an alarm when a single rotation time of the drive motor reaches a first predetermined time period or a plurality of accumulated rotation times of the drive motor reaches a second predetermined time period.